Clinical Trials in Guinea

There are about 22 clinical studies being (or have been) conducted in Guinea.
The country of the clinical trial is determined by the location of where the clinical research is being studied.
Most studies are often held in multiple locations & countries.

Principal objective Assess the operational efficacy of a strategy combining early diagnosis
and preventive antiretroviral treatment systematically reinforced from the birth* among
infants at high risk of infection with HIV** .
- in a maximum of 48 hours after delivery
- born from HIV infected mothers who received less than 4 weeks of antiretroviral
therapy prior delivery and / or HIV infection diagnosed at delivery
Intervention, a combined strategy :
After positive HIV infection screening from mother in the delivery room and put on
antiretroviral treatment of mothers with post partum according to national guidelines ,
newborns benefit :
- Early detection of HIV infection at birth
- Without awaiting the outcome of early detection result, a preventive reinforced
antiretroviral treatment (zidovudine, lamivudine, nevirapine or zidovudine, lamivudine
if their mother is infected with HIV-2), from birth for 12 weeks.
- Regular HIV screening until the end of breastfeeding or later to 18 months.
- In case of positive results of an HIV test, an antiretroviral treatment with zidovudine,
lamivudine, lopinavir, ritonavir whatever serology HIV 1 or 2.

Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert
Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin
Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to
presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and
middle income countries, most drug sensitivity testing relies on phenotypic drug resistance
testing, which takes up to 4 months. In addition, currently, culture on monthly sputum
samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant
Tuberculosis patients under treatment. Unfortunately, culture is often not locally available
and samples need to be transported from field to culture laboratories. The associated
transport delays lead to high rates of contamination and false negative culture, particularly
in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB
patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug
resistant tuberculosis in Africa) study aims to address some of them.

This study evaluates the effectiveness of fexinidazole administered to patients with g-HAT at
all stages of the disease. The aim of the present study is to provide additional information
on the effectiveness and safety of fexinidazole and to assess its use under conditions as
close as possible to those in real life, both in patients treated on an out-patient basis and
in the hospital setting, depending on clinical status

D²EFT is a randomised, open-label study in HIV-1 infected patients failing first-line
antiretroviral therapy (ART). The study compares 2 regimens of second-line ART (dolutegravir
and darunavir pharmaco-enhanced with ritonavir and dolutegravir and 2 prespecified NRTIs)
with the WHO recommended regimen of 2NRTIs plus a ritonavir-boosted PI (Standard of Care
(SOC)). 1,010 participants from 14 predominantly low-middle income countries will be followed
for 96 weeks with the primary endpoint at week 48. The design is based on the hypothesis that
one or both of the new regimens will be non-inferior to SOC in terms of virologic control
while being easier to take, economically viable and affording simplification of treatment
programs.

The purpose of this study is to evaluate the safety and immunogenicity of three vaccine
strategies that may prevent Ebola virus disease (EVD) events in children and adults.
Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA)
boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.

Background:
Some people have Ebola virus in their body for months after they recover from Ebola virus
disease. Some may have health problems from the virus while others are fine. These people may
be able to pass the virus to others. There are currently no drugs for people who have
survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734,
might help get rid of Ebola virus in semen.
Objective:
To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans.
Eligibility:
Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola
virus in their semen
Design:
Participants will be screened with:
Questions
Physical exam
Eye exam
Blood tests
2 semen samples if they have not had it tested recently
Participants must live near the study site in Liberia for 6 months.
Participants will be put into 1 of 2 study groups. They will have an infusion of either
GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The
infusion lasts 1 hour.
Participants will be observed for 1 hour after. They will provide a semen sample on infusion
day 4.
After the infusions, participants will have 5 visits in the first month, then 1 per month for
5 more months. These include giving a blood and semen sample.
Blood tests are performed before and after each infusion and the last visit (5 month visit)
will also include an eye exam.
When the study is over, if the study drug works and is safe, participants who got the placebo
can get the study drug.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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